Adderall XR (mixed amphetamine salts) capsules

WARNINGS AND PRECAUTIONS

Peripheral Vasculopathy, including Raynaud’s phenomenon

Stimulants, including Adderall XR , used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

PATIENT COUNSELING INFORMATION

Instruct patients beginning treatment with Adderall XR about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to calltheir physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Adderall XR . Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients

MEDICATION GUIDE

What is the most important information I should know about Adderall XR ?